First approvals of dabigatran for stroke prevention in AF patients in the US and Canada

Br J Cardiol 2010;17:259-63 Leave a comment
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The wait for a more convenient replacement for warfarin for use in atrial fibrillation (AF) patients is finally over in North America, where dabigatran is now available for stroke risk reduction in patients with non-valvular AF.

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The wait for a more convenient replacement for warfarin for use in atrial fibrillation (AF) patients is finally over in North America, where dabigatran is now available for stroke risk reduction in patients with non-valvular AF.

This new anticoagulant, sold as Pradaxa® by Boehringer Ingelheim, was approved for the AF indication by both the US Food and Drug Administration (FDA) and the Canadian health authority at the end of October, and launched in both markets on November 3rd.The drug is priced at a wholesale-acquisition cost of $6.75 per day.

The approval is based on findings from the RE-LY (Randomised Evaluation of Long-Term Antiplatelet Anticoagulation Therapy) trial, in which dabigatran 150 mg twice daily significantly reduced the risk of stroke and systemic embolism compared with warfarin, the longtime standard of care, with a similar risk of bleeding. 

In a surprise move, the FDA also approved a lower dose of 75 mg twice daily for patients with reduced kidney function. This dose was not tested in the RE-LY trial, but was arrived at by an FDA calculation that modelled the kinetics of the drug against renal function. The 110 mg dose that was tested in the RE-LY study was not approved. 

Dabigatran should revolutionise treatment in that, unlike warfarin, it does not need monitoring and does not have a long list of contraindications and interactions, so should be suitable and easier to manage for a great many more patients. 

Dabigatran is not yet available for stroke prevention in AF patients in the UK or the rest of Europe, where it is awaiting review by the European Medicines Agency. Currently in the UK dabigatran can only be prescribed for the primary prevention of venous thromboembolic events in adults who have undergone elective total hip or elective total knee replacement surgery. 

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